The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants were enrolled at 110 sites in the North America and Europe. The first participant was screened on 17 November 2010. The last participant observation was on 28 October 2014.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

617 participants were screened.

Reporting Groups

Description

FTC/RPV/TDF

Participants were randomized to switch from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study.

SBR/Delayed Switch

Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Safety Analysis Set: participants who were randomized and received at least one dose of study drug

Reporting Groups

Description

FTC/RPV/TDF

Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.

SBR/Delayed Switch

Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.

Total

Total of all reporting groups

Baseline Measures

FTC/RPV/TDF

SBR/Delayed Switch

Total

Overall Participants Analyzed [Units: Participants]

317

159

476

Age [Units: Years]Mean (Standard Deviation)

41 (9.2)

43 (9.7)

42 (9.4)

Gender [Units: Participants]

Female

44

15

59

Male

273

144

417

Ethnicity (NIH/OMB) [Units: Participants]

Hispanic or Latino

51

31

82

Not Hispanic or Latino

264

128

392

Unknown or Not Reported

2

0

2

Race/Ethnicity, Customized [Units: Participants]

White

241

124

365

Black or African American

61

22

83

American Indian or Alaska Native

3

2

5

Asian

6

2

8

Other

6

9

15

Region of Enrollment [1] [Units: Participants]

Austria

18

8

26

Belgium

15

13

28

Canada

15

10

25

France

29

14

43

Germany

31

12

43

Italy

16

10

26

Puerto Rico

16

2

18

Spain

15

5

20

United Kingdom

17

6

23

United States

149

81

230

[1]

Four participants in the Switch to FTC/RPV/TDF group and 2 participants in the Stay on Baseline Regimen (SBR) group were randomized but were not treated. These subjects are included in the analysis of the baseline characteristic "Region of Enrollment" but are not included in the analysis of other baseline characteristics.

Baseline HIV-1 RNA Category [Units: Participants]

< 50 Copies/mL

299

152

451

50 to < 200 Copies/mL

10

6

16

200 to < 400 Copies/mL

2

0

2

400 to < 1000 Copies/mL

2

0

2

≥ 1000 Copies/mL

4

1

5

Stratification based on antiretroviral (ARV) use [Units: Participants]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or